Efficacy and Safety of Topically Applied Medical Therapy for the Treatment of Pediatric Glaucoma
The study will assess the ocular hypotensive effect of latanoprost and dorzolamide in a selected sample of patients affected by primary Pediatric Glaucoma (PG), refractory to surgical procedures. Safety will be assessed, too.In the first version of the protocol 96 eyes were forecasted to complete the enrolment. The protocol was then amended and now to complete the study 68 eyes should be included.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Prostaglandin Analogue and Carbonic Anhydrase Inhibitor for the Treatment of Pediatric Glaucoma|
- percentage of "responder" [ Time Frame: 3 years ] [ Designated as safety issue: No ]defined as those eyes in which the decrease of intraocular pressure (IOP) of at least 20% with respect to baseline assessment will be achieved and maintained during the 3-year period of study duration
- Time to treatment failure (TTF) [ Time Frame: 3 years ] [ Designated as safety issue: No ]calculated as the time from the date of baseline visit to the date in which the medical treatment will be stopped, since IOP control will be considered not satisfactory
- Incidence of adverse events (AEs) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]The occurrence of the following events will be monitored: growth of the eyelashes (hypertrichosis), changes iris colour, corneal epitheliopathy, allergic conjunctivitis, increase of central corneal thickness, non-serious and serious adverse event occurrence.
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
According to IOP assessment, the eye will receive Latanoprost, Dorzolamide or both.
Drug: Latanoprost, Dorzolamide
Single arm, prospective, experimental study. Due to ethical reasons and in order to adhere as much as possible to current clinical practice, the presence of a control arm is not planned. Due to the non-comparative nature of the study, no blinding of treatment is planned.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527682
|Azienda Ospedaliera Spedali Civili di Brescia|
|Brescia, Italy, 25123|
|A.O. Universitaria " Policlinico Vittorio Emanuele" P.O. Rodolico|
|Catania, Italy, 95123|
|Principal Investigator:||Luciano Quaranta, MD||Università di Brescia, Spedali Civili di Brescia|